FDA strengthens warning on antidepressant Paxil
The Food and Drug Administration wants an antidepressant drug reclassified. The FDA is strengthening its warning that Paxil may be associated with birth defects. It cites a new study showing an increased risk of fetuses developing heart defects.
The agency has asked manufacturer GlaxoSmithKline to reclassify the drug as “Category D” for pregnant women. That means that studies have shown a risk to the fetus.
But the FDA says the benefits of Paxil may outweigh the potential risk.
The agency says two studies of pregnant women taking Paxil during the first trimester show their babies are up to twice as likely to have heart defects. The FDA is asking doctors not to prescribe the drug to women in their first three months of pregnancy unless there are no other options.
Source: Volunteer TV.
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